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Factor assay (VIII and IX) results in the College of American Pathologists Survey Program (1980-1982)
Abstract:
It has become apparent that mild factor deficiency states (i.e., Factor VIII, IX, and von Willebrand's syndrome) are frequent causes of postoperative bleeding and hemorrhagic complications following trauma. Despite their incidence, they frequently are not diagnosed or in some instances are misdiagnosed. In an attempt to improve the level of performance of factor assays, the College of American Pathologists recently has introduced factor-deficient plasmas into their proficiency testing program. Initially, plasmas deficient in Factor VIII were evaluated and more recently, plasmas deficient in Factors IX and XI were included. The results of the initial survey programs indicated a lack of precision and accuracy of Factor VIII and IX assays. Similar difficulties also were encountered with plasmas deficient in Factor XI. Extensive information also was gathered on the fundamentals of laboratory performance of factor assays. This information included data regarding preparation of the standard activity curves, source of deficient substrate plasmas, number of patient sample dilutions, etc. Also, it was evident that various thromboplastins have different degrees of sensitivity to the various deficiency states. A portion of this variability may be attributable to the choice of activator, however, it would appear that the phospholipid content of the partial thromboplastins is of equal importance.
Insights
Mild factor deficiencies, such as Factor VIII and Factor IX, often cause bleeding after surgery or trauma but are frequently missed. Proficiency testing revealed inaccuracies in assays for these crucial clotting factors.
Area of Science:
- Hematology
- Clinical Pathology
- Laboratory Medicine
Background:
- Mild factor deficiencies (Factor VIII, IX, von Willebrand syndrome) are common causes of postoperative bleeding and trauma-related hemorrhage.
- These conditions are often underdiagnosed or misdiagnosed, impacting patient care and outcomes.
Purpose of the Study:
- To evaluate the precision and accuracy of laboratory assays for clotting factors.
- To identify sources of variability in factor assays and improve diagnostic performance.
Main Methods:
- Utilized factor-deficient plasmas in the College of American Pathologists' proficiency testing program.
- Assessed assays for Factor VIII, IX, and XI deficiencies.
- Gathered data on standard curve preparation, substrate plasmas, and sample dilutions.
Main Results:
- Initial proficiency surveys indicated significant lack of precision and accuracy in Factor VIII and IX assays.
- Similar difficulties were observed with Factor XI assays.
- Variability in thromboplastin sensitivity to factor deficiencies was noted, influenced by activators and phospholipid content.
Conclusions:
- Current laboratory assays for mild factor deficiencies exhibit suboptimal precision and accuracy.
- Standardization of thromboplastins and assay conditions is crucial for reliable diagnosis.
- Improved proficiency testing is essential to enhance the detection of these bleeding disorders.